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BRIEF TITLE: Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies


  • Org Study ID: TTX-030-001
  • Secondary ID:
  • NCT ID: NCT03884556
  • NCT Alias:
  • Sponsor: Tizona Therapeutics, Inc - Industry
  • Source: Tizona Therapeutics, Inc

Brief Summary

This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.

Overal Status Start Date Phase Study Type
Recruiting April 10, 2019 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Recommended Phase 2 Dose (RP2D)

Primary Outcome 1 - Time Frame: 1 cycle (each cycle is 21-28 days)

Condition:

  • Solid Tumor
  • Lymphoma

Eligibility

Criteria:
Abreviated Inclusion Criteria

1. Advanced solid tumor malignancy or relapsed/refractory lymphoma, or

- eligible to receive single-agent pembrolizumab as standard of care, or

- eligible to receive single-agent docetaxel as standard of care, or

- advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus
nab-paclitaxel as standard of care.

2. Age 18 years or older, is willing and able to provide informed consent

3. Evidence of measurable disease

4. Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance
status of 0-1

Abbreviated Exclusion Criteria

1. History of allergy or hypersensitivity to study treatment components. Patients with a
history of severe hypersensitivity reaction to any monoclonal antibody.

2. Use of investigational agent within 28 days prior to the first dose of study treatment
and throughout the study

3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive
therapy

4. History of severe autoimmune disease

5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing
treatment
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Anthony Tolcher, MD

Role: Principal Investigator

Affiliation: NEXT Oncology

Overall Contact

Name: Tizona Therapeutics, Inc.

Phone: 888-585-2990

Email: clinicaltrials@tizonatx.com

Locations

Facility Status Contact
Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
Recruiting Reisy Guedes
305-243-8807
rxg957@med.miami.edu
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Referral Line
615-329-7478
Cann.researchreferrals@scresearch.net
NEXT Oncology
San Antonio, Texas 78229
United States
Recruiting Sarah Gomez
210-580-9521
sgomez@nextsat.com